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Front Pointer Elekta
EUDAMEDFDA UDIClass I (EU MDR)
Ref 11-360Model Front Pointer Elekta
Identity
- Trade Name
- Front Pointer Elekta EUDAMEDMechanical Front Pointer FDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- Mechanical Front Pointer. Elekta. EUDAMEDElekta Compatible, direct mount FDA UDI
- Model / Reference
- Front Pointer Elekta EUDAMED11-360 EUDAMEDFDA UDI
- Description
- Elekta Compatible, direct mount FDA UDI
Identifiers
- Primary DI / UDI-DI
- B365113600 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B36511360FPQG EUDAMED
- Direct Marketing DI
- B365113600 EUDAMED
- 510(k) Number
- K990997 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11010199 LINEAR ACCELERATORS – OTHER EUDAMED
- GMDN Term
- Accelerator system quality assurance device FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Front Pointer Elekta by Aktina Medical Corp — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B36511360FPQG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aktina Medical Corp
- EUDAMED SRN
- US-MF-000005935
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (2)
- EUDAMED 7317cf73-b670-4852-abde-da8f5ac8dced 61 fields · synced Oct 6, 2026
- FDA UDI a2a52249-0176-4d4b-b746-8a7acb72fb6d 34 fields · synced May 30, 2026